EFSA finds no reason to alter aspartame ADI

The European Food Safety Authority (EFSA) said there is no indication that aspartame causes cancer following its assessment of a study that linked regular intake of the sweetener with increased risk of certain cancers.

EFSA’s panel on Food Additives and Nutrient Sources added to Food (ANS) was asked by the European Commission for its scientific opinion on the results of the long-term carcinogenicity study of rats that were exposed aspartame.

EFSA has now published its opinion on the research, which is the second such study by The Cesare Maltoni Cancer Research Center of the European Ramazzini Foundation (ERF) published in June 2007 by Soffritti et al.

The panel concluded that on the basis of all the evidence currently available, including the previous ERF study, there was “no indication of any genotoxic or carcinogenic potential of aspartame and that there is no reason to revise the previously established ADI (Acceptable Daily Intake) for aspartame of 40 mg/kg bw/day”​.

Aspartame is commonly used in food products for the diet or low calorie market, including soft drinks and chewing gums. It was approved for use in the early 1980s but there has been controversy over its safety.

Although not included in the new review of genotoxicity or carcinogenic potential, previously concerns have been raised following links between excessive intakes of the sweetener and neurological and behavioural disturbances (European Journal of Clinical Nutrition​, 2008, Vol. 62, Pages 451-462). These challenged an earlier review in the journal Critical Reviews in Toxicology​ that reported no credible evidence of neurotoxicity when aspartame was consumed at recommended levels.The ERF published its first study on the sweetener's link to cancer in 2005. After reviewing this initial ERF data, EFSA also concluded that the findings did not provide sufficient evidence to call into question their classification of aspartame as safe for human consumption.

Ailbhe Fallon, managing director of Fallon-Currie who described herself as a spokesperson for Aspartame Information, told FoodNavigator.com that the latest opinion by EFSA came as no surprise.

She said the Ramazzini Institute had released several studies over the past few years and EFSA had an obligation to look at them.

Fallon added: “The problem is that when EFSA asks them (ERF) to elaborate on their studies it either provides no date to support it or what is provided is criticised by EFSA for its methodology or otherwise.”​

Meanwhile she said the market for low and no-sugar beverages sweetened with aspartame was growing and the impact of such reports at consumer level was “limited to nothing”.

The study​

The second ERF study reported the incidence of total malignant tumours, lymphomas/leukaemias and mammary carcinomas in rats for different doses of aspartame. The authors said the results confirmed and reinforced their first experimental demonstration of aspartame’s multipotential carcinogenicity at a dose level close to the human ADI.

They also suggested that carcinogenic effects are increased with lifespan exposure to aspartame begins during foetal life.

The panel’s assessment was aimed at establishing the relevance of the reported findings to human health.

Among its conclusions, EFSA said that certain necessary data was not provided by the authors.

In addition, an EFSA spokesman told FoodNavigator.com: “Most of the lymphomas and leukaemias reported in the study appear to have developed in rats showing signs of chronic respiratory disease rather than being caused by their treatment with aspartame. ​​“The increased incidence of mammary tumours is not considered indicative of a carcinogenic potential since the incidence of mammary tumours in female rats is rather high and varies considerably between carcinogenicity studies. ​​“Moreover the increased incidence of mammary tumours in female rats reported in the study was not found in the previous ERF study, in which much higher doses of aspartame were tested.”​

This article has been amended from the original, which implied that a link between aspartame consumption and neurological and behavioural disturbances was firmly established. This view has been challenged by others in the scientific community.​